<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20171016036805N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-08</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of multimedia advice through smartphones on physical activity and quality if life</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Internet-delivered computer-tailored multimedia advice through smartphone on physical activity and quality of life among healthy individuals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>148</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27422</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Purpose: Lifestyle change, Physical activity increase, Randomization description: Simple randomization using computer software specially designed for this study, Blinding description: Participants were informed about the study and the possibility that they may be assigned to the intervention or control group randomly (and signed an informed consent form) but were blinded to which group they were assigned. Healthcare providers and investigators who designed and gave tailored feedbacks to participants were aware of group assignments. Data collectors and outcome assessors were blinded to group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy Individuals.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in a personally-tailored manner in multimedia format and weekly reminders and feedbacks. Intervention 2: Control group: general aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in multimedia format.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All collected deidentified IPD

When:
6 months after publication

To whom:
Only available for people working in academic institutions

Conditions:
Relevant researches

Where to obtain:
Farough Taee MD
e-Mail: faroughtaee@gmail.com
Mobile: 00989033936472
PO: 1396933968

How to obtain:
All collected raw deidentified IPD and the parts of analysis that will be published will be available. The best means of contacts is through e-Mail. We shall send you the required data within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8860 0030</telephone>
        <email>faroughtaee@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8860 0030</telephone>
        <email>faroughtaee@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-65 years of age
Physically and mentally healthy individuals
Access to Internet and smartphone
Basic knowledge of working with Internet and smartphone
Pass the Physical Activity Readiness Questionnaire (PAR-Q)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>High Cardiovascular Risk (Hx, Lab, Ph/E)
History of Cardiovascular Problems (Uncontrolled Hypertension, Valvular Heart Disease except for MVP, CHF, MI or CVA in past 6 months, Peripheral Arterial Disease)
History of Cancer
Significant Unexplained Weight Loss (more than 10% of weight within 6 months)
Advanced Pulmonary Disease (Asthma or COPD)
Disability or condition preventing the participant from increasing his/her physical activity (Low Back Pain, Osteoarthritis)
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in a personally-tailored manner in multimedia format and weekly reminders and feedbacks.</i_keyword>
      <i_keyword>Control group: general aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in multimedia format</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical Activity (METs.min/week), Moderate to Vigorous Physical Activity (min/week), Body Mass Index (kg/m^2), Quality of Life (SF-36 questionnaire). Timepoint: Before intervention, 2 weeks after intervention. Method of measurement: World Health Organization's Global Physical Activity Questionnaire (GPAQ), 36-Item Short Form Survey (SF-36), Meter, Weight Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-31</approval_date>
        <contact_name>Ethics committee of Baqiyatallh  University of Medical Sciences</contact_name>
        <contact_address>Nosrati Ave., Sheykh Bahayi St. Mollasadra Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
